美国fda医疗器械中英文翻译（FDA medical devices in the United
States）
FDA medical devices in the United States
800 general rules GENERAL
801 identifies LABELING
803 medical device report MEDICAL DEVICE REPORTING
806 medical devices; correction and movement reports; MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
Registration of ESTABLISHMENT REGISTRATION AND LISTING AND INITIAL IMPORTERS OF DEVICES MANUFACTURERS DEVICE FOR
EXEMPTIONS FROM FEDERAL STATE LOCAL MEDICAL DEVICE AND REQUIREMENTS (OF) PREEMPTION medical consultation for state and local medical device requirements
809 in vitro diagnostic products IN, VITRO, DIAGNOSTIC, PRODUCTS, FOR, HUMAN, USE
810 medical equipment recall right MEDICAL DEVICE RECALL AUTHORITY
812 test instruments exempt INVESTIGATIONAL, DEVICE, EXEMPTIONS
813 [reserved] [Reserved]
814 before the listing of medical devices approved PREMARKET APPROVAL OF MEDICAL DEVICES
820 quality system regulations QUALITY, SYSTEM, REGULATION
821 medical device tracking requires MEDICAL, DEVICE, TRACKING, REQUIREMENTS (only in the field of medical devices)
822 monitor POSTMARKET SURVEILLANCE after listing
860 medical device classification procedures MEDICAL, DEVICE, CLASSIFICATION, PROCEDURES
861 performance standards setting procedures PROCEDURES, FOR, PERFORMANCE, STANDARDS, DEVELOPMENT
862 clinical chemistry and clinical toxicology instruments CLINICAL, CHEMISTRY, AND, CLINICAL, TOXICOLOGY, DEVICES
864 hematology and pathology instruments HEMATOLOGY, AND, PATHOLOGY, DEVICES
866 immunology and microbiology instruments IMMUNOLOGY, AND, MICROBIOLOGY, DEVICES
868 ANESTHESIOLOGY DEVICES instruments of Anesthesiology
870 cardiovascular instruments CARDIOVASCULAR DEVICES
872 dental instruments DENTAL DEVICES
874 ear, nose, and pharynx instruments EAR, NOSE, AND, THROAT, DEVICES
876 - GASTROENTEROLOGY-UROLOGY DEVICES gastroenterology Urology Devices
878 general and orthopedic instruments GENERAL, AND, PLASTIC, SURGERY, DEVICES
880 general hospitals and individuals use instruments GENERAL, HOSPITAL, AND, PERSONAL, USE, DEVICES
882 neurological instruments NEUROLOGICAL DEVICES
884 obstetrics and Gynecology instruments OBSTETRICAL, AND, GYNECOLOGICAL, DEVICES
886 ophthalmic instruments OPHTHALMIC DEVICES
888 orthopedic instruments ORTHOPEDIC DEVICES
890 internal medicine equipment PHYSICAL, MEDICINE, DEVICES
892 radiological instruments RADIOLOGY DEVICES
895 banned instruments BANNED DEVICES
898 electrode lead wire and patient cable performance standard PERFORMANCE, STANDARD, FOR, ELECTRODE, LEAD, WIRES, AND,, PATIENT, CABLES
Chapter I SUBCHAPTER I QUALITY MAMMOGRAPHY STANDARDS ACT
900 mammography, MAMMOGRAPHY
Chapter J - Radiology health (SUBCHAPTER, J, RADIOLOGICAL, HEALTH)
1000 general rules GENERAL
1002 records and reports RECORDS AND REPORTS
NOTIFICATION,, DEFECTS, OF, OR, FAILURE, TO, COMPLY
1004 repurchase, repair, or replace REPURCHASE, REPAIRS, OR, REPLACEMENT, OF, ELECTRONIC, PRODUCTS of electronic products
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1005电子产品的进口进口电子产品
1010电子产品的性能标准：总则性能标准的电子产品：一般
1020电离辐射发生产品的性能标准电离辐射产品的性能标准
1030微波与射电频率发生产品的性能标准性能标准微波和射频发射产品
1040发光产品的性能标准发光产品的性能标准
1050声波、次声波和超声波发生产品的性能标准性能标准的声波，声波，超声波发生产品
第K分章―[预留的]（第k―[保留]）
第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（第l―规定某些其他行为由食品药品监督管理局管理下）
1210根据《联邦进口乳法》的规章规定联邦进口牛奶法下
1230根据《联邦腐蚀性毒物法》的规章法规的联邦法案下的腐蚀性毒物
1240传染病的控制控制传染病
1250州际运输卫生州际运输卫生
1251-1269 [预留的] [保留]
用于移植的人体组织1270预期用于移植的人体组织
1271人体细胞、组织以及细胞的和基于组织的产品人体细胞、组织和细胞的和基于组织的产品
1272-1299 [预留的] [保留]
第Ⅱ章―司法部强制执行局（第Ⅱ―缉毒局、司法部）
1300定义定义
1301管制物质的制造者、分销者和调剂者的登记注册制造商，分销商，和控制物质的分配器
1302对管制物质的标识与包装要求标识和控制物质的包装要求

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